Microsoft word - simultaneous spectrophotometric estimation of naproxen and esomeprazole magnesium by area under curve method

International Journal of Pharmacy Research (2012), 1(1), 1-3 www.sirejournals.com ISSN 2319-4855 (Online) SIMULTANEOUS SPECTROPHOTOMETRIC ESTIMATION OF NAPROXEN AND ESOMEPRAZOLE MAGNESIUM BY AREA UNDER CURVE METHOD1Department of Pharmaceutical Analysis, Adhiparasakthi College of Pharmacy,
*Corresponding author: pharmacy.suresh@gmail.com
ABSTRACT
A new, simple, economical, precise and accurate spectrophotometric method has been developed for
the simultaneous estimation of Naproxen and Esomeprazole magnesium in their granules. The Area under curve method in which the wavelength ranges 234-224 nm and 307-297 nm is used for the estimation of the drugs based on two simultaneous equations. Both the drugs and their mixture obey Beer-Lamberts law at selected wavelength ranges at given concentration range. The result of analysis has been validated statistically and recovery studies confirmed the accuracy of the proposed methods.
Key Words: Naproxen, Esomeprazole magnesium, Area under curve method. 1. INTRODUCTION
Naproxen, (2S)-2-(6 Methoxynaphthalen-
2-yl) propanoic acid is a non steroidal anti-
Pharmacopoeia, 2009). Spectreophotometric and
inflammatory drug (NSAID) commonly used for
the reduction of pain, fever, inflammation and
individual drug formulations. To the best of our
knowledge no simple, rapid, easy and economic
osteoarthritis, kidney stones, rheumatoid arthritis,
analytical method like UV spectrophotometric has
psoriatic arthritis, gout, ankylosing spondylitis,
been reported for their combination, till date.The
menstrual cramps, tendinitis, bursitis and primary
present work describes the development of
dysmenorrhea. It works by inhibiting both the
spectrophotometric method for simultaneous
magnesium, Bis (5-methoxy-2-[(S)-[(4-methoxy-
magnesium. The method described herein, is
3, 5- dimethyl-2- pyridinyl) methyl] Sulfinyl] - 1
simple, accurate, precise and economical with the
H - benzimidazole - 1- yl) magnesium trihydrate is
advantage that there is no need of prior separation
a proton pump inhibitor used in the treatment of
of both the components, for carrying out their
dyspepsia, peptic ulcer disease, gastroesophageal
reflux disease and Zollinger-Ellison syndrome.
The combination is indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid
2. MATERIAL AND METHODS
arthritis and ankylosing spondylitis and to
decrease the risk of developing gastric ulcers in
Schimadzu UV 1700 spectrophotometer was
patients at risk of developing NSAID associated
used for the experiment with 10mm matched
gastric ulcers. The official method for independent
determination of naproxen is by titrimetry(British
Pharmacopeia,1993) and that for esomeprazole
All rights reserved (2012) Society for Integrated Rural Empowerment International Journal of Pharmacy Research (2012), 1(1), 1-3 www.sirejournals.com ISSN 2319-4855 (Online) Reagents and chemicals
further diluted to get the concentration in the
Analytically pure samples of Naproxen and
Beer’s range. The area of the resulting solution at
Esomeprazole magnesium were kindly supplied
234-224 nm and 307-297 nm was measured and
these values were substituted in the simultaneous
pharmaceuticals respectively, and used as such.
equations to get the concentration of both the
Preparation of synthetic mixture (Granules)
Esomeprazole-20 mg. So, considering 750 mg as
the total weight of tablet, the formula for the
preparation of Granules equivalent to 50 tablets
A1, A2 = the area of the sample solution at two
ax1 and ax2 = area of naproxen at 234-224 nm and
ay1 and ay2 = area of esomeprazole magnesium at
Microcrystalline cellulose - 170 mg (22%)
234-224 nm and 307-297 nm, respectively.
Cy = concentration of esomeprazole magnesium.
Area under curve method (Vishnu P and Vikram
The accuracy of the method was checked by
recovery studies, by addition of standard drug
For Area under curve method, the specific
solution to pre-analyzed sample solution at three
wavelength intervals were selected for both the
different concentration levels (80%, 100% and
drugs from their zero order spectras, 234-224 nm
120%) within the range of linearity for both the
was chosen for the estimation of naproxen and
drugs. The intra day and inter day precision
307-297 nm was chosen for the estimation of
studies were performed at the test concentration of
esomeprazole magnesium. For the analysis of
both the drugs by doing the assay three different
Naproxen and Esomeprazole magnesium by the
times in the same day and at three different days.
proposed method, methanol followed by Borate
Ruggedness studies were performed with two
buffer (pH-9.0) is chosen as the best and
economic solvent. So it was decided to prepare
drug solutions in methanol followed by dilutions
recovery studies, precision studies and ruggedness
with Borate buffer (pH-9.0).From the standard
studies were validated by statistical evaluation.
stock solutions (50mcg/mL) of both the drugs,
linearity studies were performed between the
3. RESULTS AND DISCUSSION
concentration range of 1.0 to 6.0 mcg/mL for both
The correlation coefficient for both the
wavelength ranges for both the drugs was
drugs was found to be 0.999. This indicates that
both the drugs obey Beer’s law and they were
linear at the selected concentration range. The
concentration in x axis and area in Y axis.
percentage purity of granules was found to be
Standard stock solution of the granules
99.43 ± 0.5994 and 100.56 ± 1.3945 for Naproxen
and Esomeprazole magnesium, respectively. The
magnesium was prepared in specified solvent and
All rights reserved (2012) Society for Integrated Rural Empowerment International Journal of Pharmacy Research (2012), 1(1), 1-3 www.sirejournals.com ISSN 2319-4855 (Online) results of the assay, recovery studies, precision
and ruggedness studies were shown in table -1.
Table1: Results of assay and validation parameters of naproxen and esomeprazole magnesium granules
% Estimated*
Recovery**
Inter day***
Intraday***
Analyst 1*
Analyst 2*
*mean of six observations, ** mean of nine observations, *** mean of three observations
validation parameters of the proposed method
proves that the method was simple, accurate and
precise. So the method can be used for the routine
analysis of the both the drugs in combination.
simultaneous determination of Dutasteride
and Tamsulosin in combined tablet dosage
ACKNOWLEDGEMENTS
providing samples of pure drugs for the study.
its application to uniformity of content in
Tablet and Capsule. International Journal REFERENCE of Pharmaceutical Sciences Review and Research (2010), 2(2). 63-67.
International edition, Office of British
2. The United States Pharmacopoeia Volume
International Journal of Pharmaceutical Sciences Review and Research (2010),
Pharmaceutical Excipients. 4th edition.,
Pharmaceutical Association (2003), 108, 354, 603, 641. All rights reserved (2012) Society for Integrated Rural Empowerment

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